LTR Pharma Limited (ASX:LTP) (“LTR Pharma”, “the Company”), a Company focused on improving men’s health through clinical development and commercialisation of an innovative nasal spray treatment for erectile dysfunction (“ED”), SPONTAN®, is pleased to provide its Appendix 4C for the quarter ended 30 September 2024.
Highlights:
- SPONTAN® prescribed to first patients under the Therapeutic Goods Administration's (TGA) Special Access Scheme (SAS) and Authorised Prescriber Scheme (APS).
- Secured global Co-Development Agreement with Aptar Pharma for SPONTAN for global markets.
- As at 30 September 2024, the Company held a cash balance of $12.05 million.
- Subsequent to quarter end, LTR Pharma released SPONTAN’s final clinical study results showing it achieves 470% faster absorption than oral PDE5 tablets (Viagra, etc.), positioning SPONTAN as a potential market disruptor in the global ED market.
Corporate Update
During the quarter, LTR Pharma achieved several significant milestones in its R&D and commercial operations, positioning the Company for accelerated growth and market development.
World first prescriptions of a PDE5 (Viagra, etc) nasal spray
SPONTAN has been prescribed under the Therapeutic Goods Administration (TGA) early access schemes for unmet medical needs - for the first time, globally - marking a significant leap forward in the treatment landscape for ED. This has been facilitated via the following pathways:
- Special Access Scheme (SAS): In early August, select patients received SPONTAN via the SAS, allowing for case-by-case prescriptions.
- Authorised Prescriber Scheme (APS): On 16 August, SPONTAN was prescribed to the first patients under the APS. This scheme allows registered medical practitioners to prescribe SPONTAN to a broader class of patients with erectile dysfunction, streamlining access for those who may benefit from this innovative treatment.
The involvement of key opinion leaders (KOLs), including internationally renowned men’s health experts such as LTR Pharma’s Scientific Advisor and consultant urological surgeon, Professor Eric Chung, underscores the growing recognition of SPONTAN's potential for addressing unmet needs in ED treatment.
The TGA’s early access scheme facilitates invaluable, real-world clinical access and experience for SPONTAN. It enables medical practitioners to focus on initial patient use and clinical outcomes, and to gather patient feedback with real-world data on how patients use the product, amongst other data. Prescribers are reporting excellent feedback from patients, further validating SPONTAN's potential. This clinical experience builds a foundation for future medical publications and supports the Company’s partnering and licensing discussions, and regulatory meetings.
Over the coming quarters, LTR Pharma will continue to build on these clinical cases, enhancing SPONTAN’s product profile in real-world scenarios to improve the treatment landscape for ED and to support SPONTAN’s regulatory strategy and market positioning.
Global Co-Development Agreement
On 13 August 2024, LTR Pharma secured a global Co-Development Agreement (“the Agreement”) with Aptar Pharma, a global leader in nasal spray technology. This strategic partnership supports SPONTAN's commercialisation in key markets, including the US. The Agreement combines LTR Pharma's pharmaceutical development capabilities with Aptar Pharma's expertise in nasal spray technology.
Preparation has commenced in the quarter to initiate the following activities to support a streamlined regulatory pathway and market access for SPONTAN:
- Extractable and leachable (E&L) studies to further validate SPONTAN's compliance with FDA standards.
- Human Factors studies to assess how well users can follow instructions for use
- Production of FDA-compliant instructional videos to ensure proper product usage.
- Development of dedicated medical education and product supply chain technology infrastructure.
These efforts are vital in preparing for future regulatory meetings and advancing SPONTAN’s development pathway towards broader market access.
Manufacturing
To support the Company’s R&D and commercial objectives, LTR Pharma has initiated a scale-up of its manufacturing processes. This includes ongoing stability studies to extend SPONTAN's shelf life and to facilitate anticipated patient demand in 2025.
Financial Update
In July, the Company completed a capital raise of $10.5 million (before costs), complemented by a $0.4 million R&D tax incentive inflow for the FY23 financial year. As of 30 September 2024, LTR Pharma’s cash balance stood at $12.05 million. This provides a strong foundation for advancing the Company’s key strategic objectives over the coming year, including ongoing development, regulatory preparations, and further product commercialisation efforts.
During the quarter, LTR Pharma completed its pivotal clinical study and spent $536,650 in research and development, mainly comprising of its clinical study.
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of Appendix 4C totalled A$138,750 and included Director fees, salary, and superannuation for the Executive Chairman and Non-Executive Directors.
Outlook
LTR Pharma is building on its research and development success to advance its strategic objectives across multiple fronts.
After completing its successful clinical trial, the Company's primary commercial focus has been getting real-world feedback from clinicians prescribing SPONTAN through the TGA’s early access schemes. This will remain a key focus in the quarter ahead. The Company is receiving positive feedback from medical practitioners and expects this data to be valuable to our regulatory meetings and partnering discussions with global pharmaceutical companies. Building on the success of our pivotal clinical study, the Company is prioritising the publication of our comprehensive clinical data package, complemented by real-world evidence from key opinion leaders’ early prescribing experience. This dual approach of robust clinical data and real-world validation remains a central strategic priority for the quarters ahead, positioning SPONTAN’s unique advantages in the global ED market.
The Company will also actively progress its regulatory strategy to achieve broader market access for SPONTAN. In line with this, LTR Pharma retained a global regulatory and market access firm in the last quarter to provide a strategic regulatory access plan in key markets. LTR Pharma expects to receive this strategic review in the coming quarter and proceed with initiating regulatory review meetings with the FDA and TGA.
The Company remains committed to improving men's health and looks forward to updating shareholders on its progress in these key areas in the coming months.
About us:
LTR Pharma is focused on improving men’s health, physically and mentally, through the commercialisation of an innovative nasal spray treatment for Erectile Dysfunction. ED is a pressing health issue for millions of men that can negatively impact self-esteem and relationships, across multiple age brackets. LTR Pharma’s lead product SPONTAN® is set apart from existing ED therapies by its mechanism of action – intranasal delivery technology of a PDE5 inhibitor. The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less. LTR Pharma is proudly aiming to restore greater control over the timing, spontaneity, and enjoyment of sexual experiences.
Contact details:
Jane Morgan